The art of endoluminal prosthesis is well developed, being used for the deployment of implants, prosthesis and other medical devices, as well as for administering drugs and diagnostic purposes.
In particular in connection with the deployment of implants, prostheses and other medical devices, such introducers are typically provided with an outer sheath within which the device to be introduced and other necessary medical equipment is fed. In the case of a device being introduced into a patient, this is generally pre-loaded onto the introducer within the sheath. The sheath is then introduced endoluminally using, for example, the well known Seldinger technique. When the distal end of the introducer is positioned in the correct location, i.e., at the treatment site, the device to be deployed is released from the introducer into the patient. Deployment typically involves retracting the outer sheath so as to expose the device and then expanding or allowing the device to self-expand.
Current systems generally require the physician to withdraw the outer sheath by applying a manual force to a component of the outer sheath at a location near the proximal end of the introducer, which remains outside of the patient during the procedure. Typically, this is achieved by the physician pulling the outer sheath in a proximal direction whilst holding steady the components of the introducer upon which the device to be deployed is held. This generally involves a two-handed operation by the clinician and risks movement of the introducer during the deployment process such that the device fails to be deployed at the correct location within the patient. This risk is particularly acute in situations where it is required to apply a reasonably substantial force to retract the outer sheath to expose the device to be deployed, such as with larger introducer systems and introducers made to follow a tortuous path within the patient.
Attempts have been made to address the difficulties of such introducer systems and reference is made, for example, to the following patent publications: US Patent Publication No. 2005/0090887, U.S. Pat. No. 6,206,888, US Patent Publication No. 2006/0286145, U.S. Pat. No. 6,113,608, and WO 2004/014256.
The devices disclosed in the above references seek to address a part of the difficulties encountered with introducers of this nature but provide either relatively complex systems or systems which do not address the entirety of the problems. A difficulty with such systems is that it is important not to cause a physician to lose control of the deployment process. Moreover, some of the above-disclosed systems are suitable only for one specific device. However, since deployable devices vary in their nature as a result of the device itself as well as of the condition/nature of the patient, these systems would necessitate either the production of different deployment systems for different types and sizes of devices and/or particular medical procedures, or for the use of systems which are not entirely adapted to the particular medical condition of the patient sought to be treated.